NCT04965272 (CAR aGAD Ph 2) is a Phase 2 clinical trial of Cariprazine 0.75 mg/day in Generalized Anxiety Disorder, sponsored by AbbVie.

Who is sponsoring NCT04965272?

NCT04965272 is sponsored by AbbVie.

What drugs are being tested in NCT04965272?

Interventions in NCT04965272: Cariprazine 0.75 mg/day, Cariprazine 1.5 mg/day, Cariprazine 3.0 mg/day, Placebo.

What condition does NCT04965272 study?

NCT04965272 studies Generalized Anxiety Disorder.

Is NCT04965272 still recruiting?

NCT04965272 is currently withdrawn. Last updated 12 April 2022.

Last reviewed 2022-04-12 · How we verify

NCT04965272: CAR aGAD Ph 2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone

Withdrawn Phase 2 Last updated 12 April 2022

What this trial tests

Phase 2 trial testing Cariprazine 0.75 mg/day in Generalized Anxiety Disorder. Withdrawn.

Timeline

18 August 2021

Primary endpoint
24 August 2021

24 August 2021

Quick facts

Lead sponsor	AbbVie
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	18 August 2021
Primary completion	24 August 2021
Estimated completion	24 August 2021
Sites	36 locations across United States

Drugs / interventions tested

Cariprazine 0.75 mg/day — full drug profile →
Cariprazine 1.5 mg/day — full drug profile →
Cariprazine 3.0 mg/day — full drug profile →
Placebo

Conditions studied

Generalized Anxiety Disorder — all drugs for Generalized Anxiety Disorder →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 65, any sex, with Generalized Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess adverse events and the change in disease activity with cariprazine when added to ADTs compared with placebo in adult participants with GAD who have had an inadequate response to 1 or more prior ADTs alone. Cariprazine is an approved drug being developed for the treatment of GAD. The participants are placed into 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 1072 participants age 18-65 with GAD and an inadequate response to ADT alone will be enrolled in the study in the United States. After a 2-week screening period, participants will receive daily oral capsules of cariprazine of varying doses or placebo for 6 weeks, followed by a 4-week safety follow-up period for a total study duration of 10 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Generalized Anxiety Disorder

Currently open trials in the same condition.

NCT06661460 — Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders · NA · recruiting
NCT06934525 — Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings · NA · recruiting
NCT07305701 — Cohort Study on Medical Students' Mental Health · recruiting
NCT07330648 — Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder · Phase 2 · recruiting
NCT07121712 — Navigated cTBS for the Treatment of Generalized Anxiety Disorder · NA · recruiting

Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04965272 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 12 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04965272.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing